A Single-Dose Open-Label Study of XOMA 358
Research type
Research Study
Full title
A Single-Dose Open-Label Study of XOMA 358 in Subjects with Congenital Hyperinsulinism (HI)
IRAS ID
184723
Contact name
Khalid Hussain
Contact email
Sponsor organisation
Xoma
Eudract number
2015-002847-32
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
Insulin, secreted by the β cells of the Islets of Langerhans in the pancreas, is the major hormone for lowering blood glucose levels in the fasting and postprandial states. Normal control of insulin secretion is highly regulated to prevent hypoglycemia (defined in this protocol as blood glucose < 60 mg/dL). In congenital hyperinsulinism (HI), abnormalities in the insulin secretory or glucose-sensing mechanisms result in a failure to reduce pancreatic insulin secretion in the presence of lowered glucose levels, which results in inappropriately high insulin levels. Elevated insulin levels can lead to hypoglycemia and other morbidities, including neurologic damage, central nervous system deficits, and even death. This is an open-label single-dose study to evaluate 2 dose levels of XOMA 358 in subjects with congenital hyperinsulinism. XOMA 358 is a fully human monoclonal antibody (immunoglobulin G, subclass 2 [IgG2]). XOMA 358 acts to bind to insulin receptors and to reduce the action of insulin. Two cohorts, with up to 6 subjects in each cohort, are planned for evaluation. In each cohort, subjects will receive XOMA 358 as an IV infusion over 30 minutes. Each subject will participate in only 1 cohort. Male or female subjects will be enrolled, aged at least 12 years with congenital hyperinsulinemic hypoglycemia (HI). Approximately 12 subjects are planned to be enrolled into this study.
This study will be conducted at up to 3 investigative centers.
The expected study duration for each subject is up to 9 weeks (approximately 2 weeks for the Screening Period and approximately 7 weeks for the Baseline + Treatment Periods).REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0550
Date of REC Opinion
2 Nov 2015
REC opinion
Further Information Favourable Opinion